| Primary Device ID | 00850001745031 |
| NIH Device Record Key | 028fb6f2-40ed-41d9-9eb2-c197e08d335b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dental Engineering Lab-TFRK |
| Version Model Number | TFRK-6 |
| Catalog Number | TFRK-6 |
| Company DUNS | 026444360 |
| Company Name | DENTAL ENGINEERING LABORATORIES, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-805-963-2118 |
| info@delengineeringlab.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850001745031 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850001745031]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2018-10-08 |
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